PancreaticoduodenectomyNCT03699917
Goal-directed Fluid Therapy on Complications After Pancreaticoduodenectomy
An observational study of Pancreaticoduodenectomy and Stroke Volume Variation, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial summary
Optimal fluid balance is critical to minimize anastomotic edema in patients undergoing pancreaticoduodenectomy. This study examined the effects of decreased fluid administration on rates of postoperative pancreatic leak and delayed gastric emptying. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreaticoduodenectomy, Stroke Volume Variation
- How many people
- 64 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2015to 31 Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Operations were performed at a high-volume center by one of four fellowship-trained hepatopancreatobiliary surgeons using an open approach. All patients underwent an open approach for pancreaticoduodenectomy.
Who may be able to join
- pancreatic adenocarcinoma, neuroendocrine tumors, chronic pancreatitis, non-adeno malignancy, and other benign lesion
Who cannot join
- venous resection and reconstructive involving the portal venous system
- estimated blood loss exceeding two liters
- high dose steroid administration
- use of irreversible electroporation for margin enhancement
- lack of SVV equipment or inconsistent SVV recordings
- use of the robotic surgical system
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Carolinas Medical Center
Charlotte, North Carolina, 28204
Carolinas Medical Center
Charlotte, North Carolina, 28232
About this study
Official title: The Impact of Intraoperative Goal-directed Fluid Therapy on Complications After Pancreaticoduodenectomy
Optimal fluid balance is critical to minimize anastomotic edema in patients undergoing pancreaticoduodenectomy. This study examined the effects of decreased fluid administration on rates of postoperative pancreatic leak and delayed gastric emptying.
Read the detailed description
Retrospective study of 10564 patients undergoing pancreaticoduodenectomy at a single institution from January, 2015 through July, 2016. Stroke volume variation (SVV) was tracked and titrated during the procedure.
All patients were seen preoperatively in the department clinic setting, and indications for pancreaticoduodenectomy were for pancreatic adenocarcinoma, neuroendocrine tumors, chronic pancreatitis, non-adeno malignancy, and other benign. benign and malignant disease.
Patients were excluded if they had any of the following during surgery: venous resection and reconstructive involving the portal venous system; estimated blood loss exceeding two liters; high dose steroid administration; use of irreversible electroporation for margin enhancement; lack of SVV equipment or inconsistent SVV recordings; use of the robotic surgical system.
Primary outcomes measures were recorded for each patient were: pancreatic leak and delayed gastric emptying. Pancreatic leak was defined according to the international study group for pancreatic fistulas: "an external fistula with a drain output of any measurable volume after postoperative day three with an amylase level greater than three times the upper limit of the normal serum value." Delayed gastric emptying was defined clinically as persistent postoperative emesis requiring nasogastric tube placement, prokinetic agents, or hospital readmission for endoscopic gastrostomy placement.
A comparative analysis of postoperative complications was performed between patients with a median SVV < 12 during the extirpative and reconstructive phases of the procedure compared with patients with an SVV > 12. The investigators chose an SVV value of greater than 12 to represent a "dry" state because previous studies have shown that this value represents decreased fluid administration.
- Conditions
- Pancreaticoduodenectomy, Stroke Volume Variation
- Keywords
- Fluid therapy, gastric emptying, pancreatic leak, pancreaticoduodenectomy, stroke volume variation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with SVV < 12 | Patients undergoing pancreaticoduodenectomy with an intraoperative stroke volume variation of less than 12. | |
| Patients with SVV > or = 12 | Patients undergoing pancreaticoduodenectomy with an intraoperative stroke volume variation of greater than or equal to 12. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications (Pancreatic leak and delayed gastric emptying)
Number of patients with postoperative pancreatic leak and postoperative delayed gastric emptying. Stroke volume is calculated using measurements of ventricle volumes from an echocardiogram and subtracting the volume of the blood in the ventricle at the end of a beat (called end-systolic volume) from the volume of blood just prior to the beat (called end-diastolic volume).
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Jan 2015
- Primary completion31 Jul 2016
- Study completion31 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreaticoduodenectomyStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dionisios Vrochides, MD, Principal investigator, dionisios.vrochides@atriumhealth.org
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699917
- Sponsor's protocol ID
- IRB #:06-12-34E
- Status last verified
- Oct 2018
- First submitted
- 3 Oct 2018
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Intraoperative Goal-directed Fluid Therapy on Complications After Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT03699917
- Acronym / sponsor ID
- IRB #:06-12-34E
- Conditions
- Pancreaticoduodenectomy, Stroke Volume Variation
- Keywords
- Fluid therapy, gastric emptying, pancreatic leak, pancreaticoduodenectomy, stroke volume variation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Jul 2016 (actual)
- Study completion
- 31 Jul 2016 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Optimal fluid balance is critical to minimize anastomotic edema in patients undergoing pancreaticoduodenectomy. This study examined the effects of decreased fluid administration on rates of postoperative pancreatic leak and delayed gastric emptying.
Detailed description
Retrospective study of 10564 patients undergoing pancreaticoduodenectomy at a single institution from January, 2015 through July, 2016. Stroke volume variation (SVV) was tracked and titrated during the procedure.
All patients were seen preoperatively in the department clinic setting, and indications for pancreaticoduodenectomy were for pancreatic adenocarcinoma, neuroendocrine tumors, chronic pancreatitis, non-adeno malignancy, and other benign. benign and malignant disease.
Patients were excluded if they had any of the following during surgery: venous resection and reconstructive involving the portal venous system; estimated blood loss exceeding two liters; high dose steroid administration; use of irreversible electroporation for margin enhancement; lack of SVV equipment or inconsistent SVV recordings; use of the robotic surgical system.
Primary outcomes measures were recorded for each patient were: pancreatic leak and delayed gastric emptying. Pancreatic leak was defined according to the international study group for pancreatic fistulas: "an external fistula with a drain output of any measurable volume after postoperative day three with an amylase level greater than three times the upper limit of the normal serum value." Delayed gastric emptying was defined clinically as persistent postoperative emesis requiring nasogastric tube placement, prokinetic agents, or hospital readmission for endoscopic gastrostomy placement.
A comparative analysis of postoperative complications was performed between patients with a median SVV < 12 during the extirpative and reconstructive phases of the procedure compared with patients with an SVV > 12. The investigators chose an SVV value of greater than 12 to represent a "dry" state because previous studies have shown that this value represents decreased fluid administration.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with SVV < 12 | – | –Patients undergoing pancreaticoduodenectomy with an intraoperative stroke volume variation of less than 12. |
| Patients with SVV > or = 12 | – | –Patients undergoing pancreaticoduodenectomy with an intraoperative stroke volume variation of greater than or equal to 12. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Operations were performed at a high-volume center by one of four fellowship-trained hepatopancreatobiliary surgeons using an open approach. All patients underwent an open approach for pancreaticoduodenectomy.
Key inclusion criteria (1 listed)
- pancreatic adenocarcinoma, neuroendocrine tumors, chronic pancreatitis, non-adeno malignancy, and other benign lesion
Key exclusion criteria (6 listed)
- venous resection and reconstructive involving the portal venous system
- estimated blood loss exceeding two liters
- high dose steroid administration
- use of irreversible electroporation for margin enhancement
- lack of SVV equipment or inconsistent SVV recordings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative complications (Pancreatic leak and delayed gastric emptying)
Time frame: 30 days postoperatively
Number of patients with postoperative pancreatic leak and postoperative delayed gastric emptying. Stroke volume is calculated using measurements of ventricle volumes from an echocardiogram and subtracting the volume of the blood in the ventricle at the end of a beat (called end-systolic volume) from the volume of blood just prior to the beat (called end-diastolic volume).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dionisios Vrochides, MD principal investigator
dionisios.vrochides@atriumhealth.org
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreaticoduodenectomy and Stroke Volume Variation, run by Wake Forest University Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (Pancreatic leak and delayed gastric emptying) (time frame: 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.